Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00093665
- Lead Sponsor
- Aichi Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II, stage III, or stage IV nasopharyngeal cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy.
Secondary
* Determine overall survival and response rate in patients treated with this regimen.
* Determine compliance to this regimen in these patients.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival at 3 years
- Secondary Outcome Measures
Name Time Method Treatment completion rate Overall survival Response rate Incidence of adverse effects
Trial Locations
- Locations (7)
National Hospital Organization - Medical Center of Kure
🇯🇵Hiroshima, Japan
Kanazawa University
🇯🇵Kanazawa, Japan
Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Aichi Cancer Center
🇯🇵Nagoya, Japan
Nara Medical University Cancer Center
🇯🇵Nara, Japan
Graduate School of Medical Science at the University of Ryukyu
🇯🇵Okinawa, Japan
Mie University School of Medicine
🇯🇵Tsu, Japan
National Hospital Organization - Medical Center of Kure🇯🇵Hiroshima, Japan